MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-ONYX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Disturbances (2140)

Event Date 06/22/2023

Event Type  Injury  

Event Description

Steinberg, j.A., brandel, m.G., wali., a.R., mahata, s., rennert, r.C., santiago, d.R., pannell, j.S., khalessi, a.A., olson, s.E.Direct transorbital approach for treatment of carotid cavernous fistula: an illustrative case series.Operative neurosurgery.00:1¿10.2023.Doi: doi: 10.1227/ons.0000000000000808.Summary: endovascular techniques have become the first-line treatment for carotid-cavernous fistulas (ccfs).Direct transorbital venous access may be used if anatomic constraints limit standard transarterial or transvenous access.We describe our institutional experience with the transorbital approach for barrow type a-d ccfs.Methods: patients with ccfs undergoing transorbital endovascular treatment at our institution between 2017 and 2019 were retrospectively reviewed.Demographic, treatment, and outcome data were collected.Results: eight patients met inclusion criteria, 4 female and 4 male patients.The mean age was 43 years, with 6 rightsided ccf and 2 left-sided ccfs.Symptoms were present for an average of 1.5 months before treatment.All patients presented with eye pain and subjective visual changes.Seven (87.5%) patients presented with proptosis, 6 (75%) patients had elevated intraocular pressure (iop), and 3 (37.5%) patients had ophthalmoplegia.Six ccfs (75%) were spontaneous, and 2 ccfs (25%) were traumatic.Barrow types were a (n = 1), b (n = 1), c (n = 1), and d (n = 5).All patients underwent direct percutaneous transorbital embolization with coils fol lowed by onyx.Three patients had undergone prior transarterial and/or transvenous treatment.A radiographic cure was obtained in all patients after direct transorbital embolization.After ccf cure, cranial nerve palsies resolved in 66.7% of patients, visual acuity in the affected eye was improved or stable in 75% of patients, and iop had normalized in 85.7% of patients.Proptosis improved in all patients, with complete resolution in 75%.Conclusion: direct transorbital embolization is a safe and potentially curative treatment for all 4 barrow types of ccfs.Reported events: one patient experienced a periprocedural complication was encountered: transient elevation of iop after transorbital approach due to a retrobulbar hematoma requiring lateral canthotomy.

Manufacturer Narrative

B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the patients were embolized using a combination of coils and onyx liquid embolic.No adverse events were related to these products.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17632883
• MDR Text Key: 322073662
• Report Number: 2029214-2023-01501
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention